Drug Rules to include Liquid Antiseptic under Schedule K: Draft amendment

Download the notification: The sub-committee was constituted under the chairmanship of N K Ahooja, Drugs Controller, FDA Haryana

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Last Updated on September 24, 2021 by The Health Master

Download the notification: The ministry of health and family welfare has issued a draft amendment to include liquid antiseptics for household use after serial No. 38 under the Schedule K of Drugs Rules, 1945 to exempt the product category from the requirement of sale license, vide Notification No. GSR 628(E) dt 13-09-2021.

The exemption is from the provisions mandating sale licenses in Form 20 or Form 20A, which is expected to make the use of liquid antiseptics more accessible to the consumer. Draft amendment comes after the Drugs Technical Advisory Board (DTAB), in June, this year, recommended the exemption of these products from sales licensing through including them in the Schedule K of drugs Rules.

Schedule K

The liquid antiseptics from companies including Reckitt Benckiser and ITC have been in high demand in the market after the outbreak of Covid-19 pandemic.

However, even before this, the Drugs Consultative Committee (DCC) in 2019 set up a sub-committee to decide on whether the liquid antiseptic in the market should be regulated with a sale license or brought under the Schedule K of the Rules.

The DCC in its 55th meeting held on January 31 and February 1, 2019, has constituted a sub-committee for clarification on exemption of Dettol antiseptic liquid (cloroxylenol, terpineol and alcohol) as antiseptic and disinfectant in the country under Schedule K (Rule 123) of Drugs and Cosmetics Rules 1945 and identify such similar type of products and give its recommendations.

NK Ahooja
NK Ahooja, SDC FDA Haryana

The sub-committee was constituted under the chairmanship of N K Ahooja, Drugs Controller, FDA Haryana. As per the terms of reference, the Sub-committee in its meeting held on July 26, 2019 invited the representatives from Reckitt Benckiser, manufacturer of Dettol antiseptic liquid and ITC Limited, manufacturer of Savlon antiseptic liquid, both leading manufacturers for antiseptic liquids to offer their views.

After consideration of the available technical and legal information and detailed deliberations the sub-committee submitted its report for DCC review and deliberations. The DCC, after detailed deliberation, observed that there are numerous such products in the market which the sub-committee did not evaluate due to its specific mandate on three products only.

Hence DCC suggested that the scope of the sub-committee shall be revised and broadened to relook the matter for examination of all the available liquid antiseptic solutions in the market.

Later, the matter came up for the approval of DTAB and it has recommended the inclusion of the product category under Schedule K for exemption. The drugs specified in Schedule K are exempted from the provisions of Chapter IV of the Act and Rules to the extent and subject to the conditions specified in that Schedule.

The draft notification was issued on September 13, inviting objections and suggestions from the stakeholders, and it would be taken into consideration on or after the expiry of a period of thirty days from the date of publication of the draft in Gazette of India. It has sought the stakeholders to communicate their objections and suggestions on the draft within the timeframe, to be considered by the government before final notification.

DCC

DTAB

Technical Committee

Hathi Committee

Mashelkar Committee

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